KR20130127455A - Devices for delivering a medicament and methods for ameliorating pain - Google Patents

Abstract

A delivery device for a medicament to a patient in need of a medicament includes: (a) a first end shaped to enter the patient's nasal cavity and a second end shaped to enter the patient's nasal cavity, and between the storage position and the engaged position Movable injector; And (b) an introducer shaped to engage the nostril of the patient, the passageway shaped to slidably receive the injector, the introducer including a curve along its portion adjacent to the passageway. A method for pain relief in a patient includes: (a) introducing an injector through the patient's nasal passages into an area primarily inside and / or behind and / or below the palatal ganglion of the patient; And (b) delivering the medication from the injector upwards and / or laterally and / or anteriorly to the butterfly palate ganglion.

Description

DEVICES FOR DELIVERING A MEDICAMENT AND METHODS FOR AMELIORATING PAIN}

This application is a partial continuing application of prior application 12 / 414,300, filed March 30, 2009, which is in part a continuing application of prior application No. 12 / 184,358, filed August 1, 2008. The entire contents of both of the above-mentioned applications are incorporated herein by reference, except for the disclosure or definitions that do not conform to this application, and the disclosure or definition herein will be deemed to be predominant.

Embodiments described herein generally relate to pain relief methods and apparatus, specifically (but not exclusively), management of pain associated with headaches, facial pain, and the like.

Conventional methods for treating pain associated with headaches and facial pain are not as safe or effective as desired. For example, non-steroidal anti-inflammatory drugs (NSAIDs), such as the COX-2 brand of drugs, should be used sparingly and only for a short period of time because of the possibility of causing ulcers and heart failure-these disadvantages are additionally numerous It is exacerbated by the inefficiency of these drugs in patients. The use of drugs is likewise undesirable because of their potential addictive nature. In addition, but not limited to sumatriptan (sold under the trade name IMITREX by GlaxoSmithKline) and zolmitriptan (sold under the trade name ZOMIG by AstroZeneca). The use of tryptamine-based drugs is undesirable because of their high cost and the potential high toxicity of these drugs.

One method that has been used to control pain associated with headaches and facial pain is known as the SPG block. In this approach, trained specialists commonly use a cotton-tipped applicator moistened with anesthetic to apply the anesthetic to the butterfly pas ganglion (SPG), which is then applied into the patient's nostrils. do. Using the nasal congestion as an anatomical reference point, the applicator with a wet cotton tip is pushed up essentially blindly forward (the success of which depends very much on the skill and experience of the physician). Clearly, there are many disappointments in the efficacy and safety of this procedure. In addition, the efficacy and safety of conventional SPG blocks, although not true, have long been believed among clinicians that SPGs are located behind the epicarpal but have been significantly compromised by false beliefs.

In short, there is an urgent need among patients and clinicians to be able to use them directly by patients without the help or supervision of safer and more efficient methods and devices to achieve SPG blocks—especially trained staff.

It is intended that the scope of the invention only be limited by the appended claims, and will not be affected to any extent by the description within the context of the invention.

A device for delivery of a medicament to a patient in need of a medicament includes: (a) a first end shaped to enter the patient's nasal cavity and a second end shaped to enter the patient's nasal cavity, and the engaged position with the storage position Injector movable between; And (b) a passageway shaped to engage the nostril of the patient, the passageway shaped to slidably receive the injector, the introducer including a curve along a portion thereof adjacent to the passageway.

The method for pain relief of a patient comprises the steps of: (a) introducing an injector of the device of the type described above into an area substantially inside and / or behind and / or below the patient's nasal palate; And (b) delivering the medication up and / or laterally and / or forward toward the butterfly palate ganglion in the injector.

1 shows a cross-sectional side view of a first device for delivering a medication to a patient in need thereof prior to inserting the device into the nostril of the patient in accordance with the principles described herein.
2 shows a top plan cross-sectional view of the device of FIG. 1 taken along line 2-2.
3 shows a cross-sectional side view of the device of FIG. 1 after the introducer is engaged with the nostril of the patient in accordance with the principles described herein.
4 is a side cross-sectional view of the device of FIG. 1 after the introducer is engaged with the nostril of the patient and the introducer is moved from a storage position to an engaged position that positions the second end of the injector inwardly, posteriorly, and downwardly to the butterfly palate ganglion. Indicates.
FIG. 5 shows a central cross-sectional view of the human head with the SPG 2 shown in the correct anatomical position, behind the paraplegic palate 4.
FIG. 6 shows a side view of a second device for delivering medication to a patient in need of the medication prior to inserting the hub into a housing and having the injector in its storage position.
7 shows a partial side cross-sectional view of the device of FIG. 6 with an injector in a storage position.
8 shows a partial side cross-sectional view of the device of FIG. 6 with the injector in the engaged position.
9 shows an exploded perspective view of the device of FIG. 6.

To date, unknown and highly effective methods of alleviating pain in patients, not all but specifically related to headaches, facial pain, and the like, and easy-to-use devices that enable easy self-administration of the medicament according to these methods have been found and Described in the specification. As described further below, the methods and apparatus described herein are directed upward and / or laterally and / or forward from the region that is substantially inward and / or posterior and / or downward of the butterfly palate ganglion. Allow medication to be delivered.

The phrases “toward bowel ganglia” and similar phrases used in connection with the delivery of a medicament herein are intended to include the SPG itself and the wing palate and butterfly palate that receive the SPG.

Introductoryly, FIG. 5 is not at the back of the nasal concha (6) or at the end of the nasal cavity (8) adjacent to the body plate (9), as many clinicians have mistakenly thought it is to be at the back of the nasal concha (4). The center cross section of the human head which confirms the position of 2) is shown. In addition, the correct position of the SPG 2 is actually offset laterally from the plane of the drawing, in other words, the SPG does not lie in the two-dimensional plane with respect to the cross section shown, as many clinicians have also mistaken.

In US Pat. No. 4,886,493, Jordan Yee describes a method of performing an SPG block that inserts a tube through the nostril of a patient to deliver the medication to the wing palate that receives the SPG. Unfortunately, as shown in FIG. 3 of US Pat. No. 4,886,493, the position of the wing pawl 18 was mistaken for lying on the x-y plane that is straightly accessible from the nostril through the back of the nasal concha and tube 11. In addition to the anticipated lack of efficacy that would be expected in delivering medication to the wrong location, as a result of this aberration, the end 13 of Yee's device would almost contact dangerously sensitive plates. Since the platelets are sieve-like and communicate with the frontal lobe of the brain, introducing anesthetics adjacent to these plates is very dangerous because they can easily penetrate through the frontal lobe.

Bruce H in US Pat. No. 6,491,940 B1. Bruce H. Levin describes an alternative procedure for performing an SPG block. In contrast to its patent described above, US Pat. No. 6,491,940 B1 appears to recognize the lateral offset of the SPG because it describes a curved body 100 rather than a straight line for the introduction of anesthetic. Unfortunately, similar to its patent, Levin's patent is also shown in Levin's Figure 4A and described therein (e.g., 72 columns, lines 20-22), so that the correct location of the SPG is not the tip of the nasal cavity, but rather the nasal concha. It fails to recognize that it is the back of the dog. Thus, as in its patent, the method described in Levin's patent once again introduces an anesthetic delivery device dangerously adjacent to the plate and involves the risks and reduces the efficacy associated with it.

U. S. Patent No. 6,322, 542 B1, assigned to AstraZeneca, describes a device for delivering medication to the nasal cavity of a patient. The stated purpose of this device is to effectively deliver the medication to the posterior region of the nasal cavity (columns 1, lines 29-32), but its shape (e.g., the linearity of the tubular member 35) allows the medication to be SPG. Or not suitable for delivery adjacent thereto. Rather, the medicament will primarily be delivered to region 7 shown in FIG. 5 of the present application. Delivery of an anesthetic near the region 7 is highly undesirable because the anesthetic can easily inhibit zonal reflection, creating a risk of swallowing pneumonia.

It is not intended to be bound by any particular theory and is not intended to affect to any extent the scope of the appended claims or equivalents thereof, but to further explain the description of the apparatus and methods provided below, today the anatomy of the SPG The following background information is provided with regard to the understanding of.

SPG (also known as wing palate ganglion) is the largest group of neurons outside the cranial cavity and lies in a wing palate recess about 1-cm wide and about 2-cm high. The wing palate is bounded forward by the posterior wall of the maxillary sinus, backward by the inner plate of the wing projection, inward by the vertical plate of the palatal bone, and upward by the butterfly den. To the side, the winged palate is connected to the milk under the temple.

The SPG in the concavity is located behind the nasal nasal concha of the nose and lies several millimeters (1 mm to 5 mm) deep of the lateral nasal mucosa. SPG has a complex neural center and a number of connections. The SPG is suspended from the maxillary branch of the trigeminal nerve at the wing palate by the wing palate nerve, and lies inward to the maxillary branch when viewed from the sagittal plane. In the rear, the SPG is connected to the pterygium. The SPG itself has blades and forms the upper posterior lateral nose and pharyngeal nerves. To the tail, the ganglion (SPG) is directly connected to the large palatal nerve and the small palatal nerve.

SPG has sensory, motor and autonomic components. The sensory fibers come from the maxillary nerve, pass through the SPG, and are distributed to the nasal membrane, the palate and the pharynx. Some motor neurons are also believed to be carried to the sensory arteries.

SPG's autonomic distribution is more complex. This sympathetic component begins with ganglion sympathetic fibers from the upper thoracic spinal cord, forming white traffic branches, flowing through the sympathetic ganglia, where the ganglion fibers synapse with post-ganglion ones. Post-ganglion fibers then join the carotid artery nerve, then split and travel through deep rock nerves and pterygium nerves. After ganglion sympathetic nerves continue the pathway through the SPG to the tear glands and the nasal and palate mucosa.

SPG is generally considered functionally parasympathetic. The parasympathetic component of SPG has a pre-ganglion origin in the gastrointestinal salivary nucleus, then travels through a portion of the facial nerve, and then forms large rock nerves that form the pterygoid nerve, which ends in SPG. Within the ganglion, preganglion fibers synapse with their post-ganglion cells, continue on the nasal mucosa, and one moves along the maxillary nerve to the tear gland.

Notwithstanding the foregoing, and regardless of the currently believed theories related to the anatomy of SPG, safe and effective pain relief can be achieved using the devices and methods described below. Representative devices 10 and 54 will be described, respectively, in connection with FIGS. 1-4 and 6-9, but these representative devices are merely illustrative and alternative structures likewise used in accordance with the principles described herein. It should be understood that it can be used to convey. It is to be understood that the elements and features of the various representative devices described below may be combined in different ways to produce new embodiments that likewise fall within the scope of the present disclosure. The following figures and descriptions are provided by way of illustration only and are not intended to limit the scope of the appended claims or their equivalents.

1-4 show a representative device 10 for delivering medication to a patient in need thereof. The device 10 includes an injector 12 comprising a first end 29 shaped to leave the nose of the patient and a second end 30 shaped to enter the nose of the patient. The device 10 further includes an introducer 18 that is shaped to engage the nostril of the patient and includes a passage 48 shaped to slidably receive the injector 12. The injector 12 has a storage position before the introducer 18 is engaged with the nostril of the patient (best shown by FIG. 1), and an engagement position with the introducer 18 engaged with the nostril of the patient (most by FIG. 4). Can be seen). However, when the introducer 18 first engages with the nostril of the patient, the injector 12 is preferably in a storage position until it is intentionally moved to the engaged position (best represented by FIG. 4) under the direction of the user (FIG. 3). Best maintained by). In some embodiments, the engagement position of the injector 12 is located inside and / or below the SPG. In other embodiments, the engagement position of the injector 12 is located on the inside, bottom, and back of the SPG, as best shown by FIG. 4.

As used herein, the phrases "storage position" and "engagement position" are each intended to encompass multiple positions within a selected range. For example, in some embodiments, the extent to which injector 12 extends into the nasal cavity of a first patient (eg, a child) is such that injector 12 extends into the nostril of a second patient (eg, an adult male). It will be different from the extension. Nevertheless, the phrase “engagement position” is intended to encompass many variations in the exact position of the intranasal injector 12, any of which is appropriately considered to be inside and / or behind and / or below the SPG. . In some embodiments, the injector 12 cannot be slid within the introducer 18, but rather fixed in a predetermined position to ensure that the introducer 18 is inside and / or below the SPG when engaged with the nostril of the patient. do. In other embodiments, the injector 12 cannot be slid within the introducer 18, but rather to a predetermined position so that the introducer 18 is inward, back, and under the SPG when engaged with the nostril of the patient. It is fixed.

The injector 12 extends from the first end 29 to the second end 30 and comprises a tubular section 24 comprising a channel 22 shaped to receive medicine (so-called cobra tube in view of the extension of the tube). ). In some embodiments, the outer diameter of the tubular section 24 is about 5 mm and the inner diameter of the channel 22 is about 2 mm. Throughout this description, measurements and distances, such as the diameter given immediately above, should be strictly considered as representative only, and are never limited and / or fixed. All measurements and distances provided in this description are capable of many variations, as those skilled in the art will readily appreciate.

In some embodiments, the second end 30 of the injector 12 includes a tip 34 comprising one or a plurality of holes 36 shaped to spray the medicine upwardly and / or laterally and / or forwardly towards the SPG. And a nozzle 28 having In some embodiments, nozzle 28 is shaped to spray medicament laterally and / or upwards towards SPG, and in other embodiments, nozzle 28 is configured to spray medicament laterally, upwardly, and forwardly towards SPG. It is shaped.

In some embodiments, the nozzle 28 extends at an upward angle from the second end 30 of the injector 12. In some embodiments, the nozzles 28 extend laterally, anteriorly, and upwardly at oblique angles from about 45 degrees to about 60 degrees to accommodate various patient anatomy, where the SPG is present in the lateral cave that is behind the parapalla . In some embodiments, nozzle 28 has a length in a range from about 2 mm to about 5 mm. In some embodiments, the injector 12 is designed to show handedness, so that in some embodiments the injector 12 is shaped to engage the left nostril of the patient, while in other embodiments the injector 12 is It is shaped to engage the right nostril of the patient (the contour of the left-handed injector is generally complementary to the contour of the right-handed injector).

Introducer 18 may be aimed into the nasal cavity to provide a horizontal path that is substantially parallel to the bottom of the nasal cavity or to the bottom of the nasal passage to the inward position of the nasal concha. This self-mounting feature of introducer 18 facilitates quick and accurate use by the patient without requiring supervision from medical professionals. In some embodiments, introducer 18 provides an extended path between about 1.5 cm and about 2 cm into the nostril. Once the introducer 18 is securely placed close to the nose, the tip of the nose will tend to face upwards. The tubular section 24 of the injector 12 can then be partially or fully pushed back to the nostril. In order to meet the slightly curved nature of the internal anatomy of the nose, the passage 48 in which the tubular section 24 lies may be slightly curved with the same nostrils from about 5 to about 20 degrees. Once the tubular section 24 is in place, medication can then be transferred from the nozzle 28 to the SPG to exert the desired SPG blocking effect. In some embodiments, device 10 may be provided with any safety abutment stops to limit the degree of movement into the nostrils used in injector 12.

As best shown by FIGS. 1, 3, and 4, introducer 18 includes a first portion 44 and a second portion 38. In some embodiments, the cross-sectional area of the first portion 44 is greater than the cross-sectional area of the second portion 38. In some embodiments, the first portion 44 is generally concave and has a contour 46 shaped to complement and substantially coincide in shape with the interior of the nostril. In some embodiments, the narrow second portion 38 has a bottom surface 40 having a rounded convex portion 39 and a generally flat surface 42. The passage 48 of the introducer 18 slidably receives the tubular section 24 of the injector 12, in some embodiments between about 6 mm and about 7 mm in diameter. In some embodiments, second portion 38 of introducer 18 includes a nostril-engaging tip extending from about 1 cm to about 3 cm. In some embodiments, first portion 44 of introducer 18 extends from about 2 cm to about 3 cm. In some embodiments, introducer 18 is designed to exhibit handleability, in some embodiments introducer 18 is shaped to engage the left nostril of the patient, while in other embodiments introducer 18 is the right of the patient. It is shaped to engage the nostril (the contour of the left-handed introducer is generally complementary to the contour of the right-handed introducer).

In some embodiments, the device 10 is further in communication with a first end 29 and a channel 22 of the injector 12 and shaped to hold a medicament 16 (eg, anesthetic) ( 14). In some embodiments, as shown in FIGS. 1, 3, and 4, the container 14 is supported on a stem 26 having a lower section 31, and in some embodiments its outer diameter is a substantially tubular section. Same as that of (24). The lower section 31 may extend outwardly and / or upwardly and / or at an angle of inclination from the first end 29 of the injector 12, in some embodiments to receive the outlet 33 of the vessel 14. Connected to an upper section 32 having a shaped enlarged diameter. Similar to the lower section 31, the upper section 32 may extend outwardly and / or at an upward and / or inclined angle.

In some embodiments, the container 14 is operatively connected, mounted or otherwise secured to the upper stem section 32 and filled fully or partially with the medicament 16. Since the container 14 communicates with the channel 22 of the injector 12, the medicament 16 can be delivered along the tubular section 24 and discharged through one or more holes 36 of the nozzle 28. The container 14 may be formed of plastic, metal or the like and may be pressurized and / or pressurized to facilitate drug delivery to the channel 22. In some embodiments, the container 14 is replaced with a port (not shown) such that medication can be introduced through the port into the upper section 32 by a delivery device such as a syringe.

In some embodiments, device 10 further includes any handle 20 connected to the back of introducer 18 adjacent to first portion 44. The handle 20 communicates upwardly through the passage 48 of the introducer 18 to slidably receive the tubular section 24 of the injector 12 and provides a track 52 shaped to receive it. Groove 50. In some embodiments, the track 52 has a depth or width of about 6 mm to about 7 mm. The handle 20 is shaped to move towards the face of the patient, which causes the introducer 18 to engage the nostril of the patient by the back movement of the handle 20.

Injector 12, introducer 18, and handle 20 may be a flexible, rigid or semi-rigid polymeric material (eg, plastic, rubber, etc.), metals and alloys thereof, and the like, and combinations thereof. It can be formed of all kinds of materials including but not limited to. In some embodiments, injector 12 is formed of flexible plastic, introducer 18 is formed of elastomeric and / or elastic plastic or rubber, and handle 20 is formed of plastic. In some embodiments, one or more injectors 12, introducers 18, and handles 20 are designed from materials to be disposable and / or biodegradable.

The representative device 10 described above may be used to deliver medication up and / or laterally and / or anteriorly to the patient's butterfly palatal ganglia in accordance with the principles described herein, alternative structures likewise likewise delivering such Can be used to achieve this.

By way of example only, similar to the angular nozzle 28 provided at the second end 30 of the injector 12, a delivery tube having a curved portion shaped for insertion into the nostril of the patient at one of the ends is substantially It may be housed in a cylindrical (eg pen- or cigar-shaped) housing. The delivery tube may be formed of a flexible or semi-rigid material (eg, plastic) such that it may be maintained in a substantially linear or non-curve arrangement while in a storage position within the housing, but in an engaged position from the housing. When extended to the shape of the curve can be easily restored. In such a device, one or more inner surfaces of the outer housing may move the transfer tube to the engaged position and thereby completely or at least partially straighten or constrain the inherent curve of the delivery tube by such a time that the curve of the tube is restored. Works. In some embodiments, at least a portion of the delivery tube (eg, the end designed to release the medicament) may, if desired (eg, air, oxygen and / or other gases, and / or the medicament press the tube under pressure). When passed through).

By providing one or more of the optional markings on the cylindrical housing described above, the user can easily identify the curved direction of the delivery tube stored therein, allowing the user to deliver medication through the delivery tube by rotating the housing in a 360 degree arc. Any desired direction of spraying can be selected. By simply rotating the housing, the direction of spraying can be augmented via a continuous arc of 0 to 360 degrees. By design, one end of the housing may be fitted with a luer lock shaped to engage a syringe containing a medicament. Apart from this, the end of the housing shaped to leave the patient's nose out may be fitted with a septum or similar membrane through which the medicine can be introduced into the delivery tube received therein.

Similarly, for use to the extent that it is possible to deliver medication up and / or laterally and / or anteriorly to the patient's butterfly pas ganglia according to the present description, numerous other alternatives to the delivery devices and alternative structures described herein are provided. Variations are likewise devised. By way of example, a portion of the device shaped for insertion into a nostril of a patient (eg, a portion of the injector 12 described above) may be shaped as desired by the user (eg, injector 12). Formed from any therapeutically acceptable conformable material (eg, plastic, metal, metal alloy, etc.) capable of accepting and maintaining the increased or decreased curve of the angled nozzle 28 provided at the two ends 30. Can be. Such a feature may be desirable, for example, when a clinician wishes to tailor the exact geometry of the device prior to use in a patient in a clinical setting.

6-9 illustrate a representative device 54 for delivering medication to a patient in need thereof. The device 54 includes an injector 56 that includes a first end 58 shaped to leave the nose of the patient and a second end 60 shaped to enter the nose of the patient. The device 54 further includes an introducer 62 that is shaped to engage the nostril of the patient and includes a passage 64 shaped to slidably receive the injector 56. The injector 56 has a storage position before the introducer 62 is engaged with the nostril of the patient (best shown by FIGS. 6 and 7) and an engagement position along which the introducer 62 is engaged with the nostril of the patient (see FIG. 8). Can be moved between).

As best shown by FIGS. 6 and 7, the injector 56 is connected to a hub 66 fitted with a luer lock mechanism shaped to engage a seal (not shown) of a syringe containing medicine for delivery to a patient. . As best shown by FIGS. 7-9, the hub 66 is connected to a compressible stop bar 68. Before engaging the syringe, the hub 66 remains outside and within the housing 70 because the stop bar 68 is located in a keyed slot 72 formed by two hemispheres of the housing 70. It is shaped to withstand rotation. Press the hub 66 in the axial direction into the housing 70 (eg, by means of a syringe connected to the luer lock mechanism of the hub 66), and the stop bar 68 touches the lip 74. Move along the key slot 72 until the stop bar 68 engages the lip 74 to prevent the retraction of the hub 66 from the interior of the housing 70, and thereby the hub 66 (and the Connected syringes) are rotatable within a defined range. The irreversibility of hub 66 axis movement within the housing 70 provides a useful way of easily distinguishing between unused and unused devices—in other words, if the hub 66 is protruding from the housing 70. If not, the device is already used.

As best understood from the considerations of FIGS. 8 and 9, the stop bar 68 is further shaped to act in conjunction with a ledge 78 within the housing 70, thereby providing a hub 66 (and The angle of rotation of the syringe connected thereto is limited to a given angle (eg, clockwise of about 45 ° or counterclockwise of 45 °). Rotation over a predetermined angle (determined based on the position of the ledge 78) is prevented when the stop bar 68 is lifted up to receive the ledge 78. This feature facilitates accurate use by the user by limiting the location where the medicament can be introduced at the injector 56 to have a desired trajectory towards the target site.

As best shown by FIG. 8, the injector 56-including the flexible plastic tube with shape memory in some embodiments-maintains a slight curve imparted by the curve introducer 62 during storage. do. Due to this curve and by providing one or a plurality of holes along the side of the second end 60, the injector 56 is designed to be used in both the left and right nostrils of the patient without taking into account handleability.

In some embodiments, the diameter of one or a plurality of holes along the side of the second end 60 of the injector 56 is smaller than the outer diameter of the flexible plastic tube, thereby pressing the plunger of the syringe The liquid discharged through the hole is violently ejected. In some embodiments, depending on the flexibility of the plastic tube, the injector 56 is more curved under pressure applied to the depression of the syringe plunger (eg, away from the liquid ejecting from the hole). In some embodiments, the diameter of one or the plurality of holes is smaller than the inner diameter of the flexible plastic tube. In some embodiments, the flexible plastic tube comprises a nylon resin (eg, such as sold under the trademark PEBAX 72D). In some embodiments, the flexible plastic tube comprises Pibox 72D, has an outer diameter Φ of 0.039 ± 0.001, has a wall thickness of 0.005 ± 0.001 (ie, five inches per thousand), and a diameter of 0.005 ± 0.001 Has a hole with In some embodiments, the apertures are oriented at 50 ° in the direction oriented towards the hub. In some embodiments, introducer 62, housing 70, key slot 72, lip 74, and ledge 78 are integrally formed (in some embodiments, two complementary shaped hemispheres). Are press fit and / or adhered together, for example by adhesive, ultrasonic welding, or the like), in some embodiments, these portions comprise polycarbonate. In some embodiments, hub 66 and stopbar 68 likewise comprise polycarbonate.

A method of pain relief in a patient in accordance with the present disclosure includes delivering the medication up and / or laterally and / or forward toward the patient's butterfly palate ganglia using the device as described herein. In some embodiments, the medicament is delivered laterally and / or upwards towards the SPG. In other embodiments, the medicament is delivered laterally, up, and forward toward the SPG.

In some embodiments, a patient's method of pain relief includes (a) introducing an injector 12 through a patient's nasal passages into an area substantially inside and / or behind and / or below the SPG of the patient; And (b) delivering the medication upwards and / or laterally and / or forward from the injector 12 towards the SPG. In some embodiments, injector 12 is introduced through the patient's nasal passages into areas substantially inward and / or down of the SPG, while in other embodiments injector 12 is substantially inward, downward, and posterior to the SPG. Is introduced into the phosphorus region. In some embodiments, the medicament is delivered laterally and / or upward toward the SPG, while in other embodiments the medicament is delivered laterally, up, and forward towards the SPG. In some embodiments, the injector 12 has a second end 30 comprising one or a plurality of holes 36 through which the medicament is sprayed towards the SPG.

In some embodiments, the injector 12 is slidably received in the introducer 18 as described above, and the method further includes (c) engaging the introducer 18 with the nostril of the patient, thereby allowing a portion of the patient's nostril. Lifting up with this introducer 18; And (d) sliding the injector 12 from the storage position to the engaged position after the introducer 18 is engaged with the nostril. As described above, the engagement position of the injector 12 is located inside and / or behind and / or below the SPG, in some embodiments inside and / or below, and in other embodiments inside, below, and back to be. In some embodiments, a medicament is provided in a container 14 connected to and in communication with an injector 12 as described above, and the method further comprises (e) a container comprising a medicament for spraying the medicament toward the SPG ( Pressing 14).

In some embodiments, the method includes pushing the introducer 18 snugly and comfortably into the nostril to lift the tip of the patient's nostril, and then positioning the nozzle 28 of the injector 12 adjacent the SPG, Sliding the tubular section 24 of 12 through the passage 48 of the introducer 18 and / or sliding the tubular section 24 of the injector 12 on the track 52 of the handle 20. Steps.

All kinds of medicaments suitable for introduction into or around the SPG are designed for use in accordance with the present disclosure. The physical state of the medicament includes, but is not limited to, liquids, solids, semi-solids, suspensions, powders, pastes, gels, and the like, and combinations thereof. In some embodiments, the medicament is provided in at least partially liquid form. In some embodiments, the medicament contains an anesthetic.

Anesthetics that may be used in accordance with the embodiments described herein are ambucaine, amolanon, amylocaine, benoxysinate, bethoxycaine, biphenamine, bupivacaine, butacacaine, buttamben, butanilishka Phosphorus, Butetamine, Butoxycaine, Carticine, Cocaethylene, Cocaine, Cyclomethicaine, Dibucaine, Dimethisoquine, Dimethokine, Diferodon, Diclonin, Egononidine, Egonone, Ethyl aminobenzo Eate, ethyl chloride, ethidocaine, β-yucaine, euprocin, phenaccomine, formokine, hexylcaine, hydroxyprocaine, hydroxytetracaine, isobutyl p-aminobenzoate, rheinokine mesylate , Reboxadrol, lidocaine, meperidine, mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, mytecaine, naepine, octacaine, orthocaine, oxetazaine, paretoxocaine, phena Caine, phenol, pipecolyxidide, Piperocaine, pyridocaine, polydocanol, pramoxin, sameridine, prilocaine, propanocaine, propparacaine, propofcaine, propoxycaine, pseudococaine, pyrocaine, quinine urea, lysocaine, Lopivacaine, salicylic alcohol, tetracaine, tolycaine, trimecaine, veratridine, zolamine and the like, and combinations thereof, and all optical and / or stereoisomers thereof, and all pharmaceuticals thereof Acceptable salts include, but are not limited to.

In some embodiments, the medicament comprises an anesthetic selected from the group consisting of benzocaine, tetracaine, ropivacaine, lidocaine, water, saline, and combinations thereof. In some embodiments, the medicament comprises water and / or brine having a temperature of less than about 10 ° C, and in other embodiments less than about 5 ° C. In some embodiments, the medicament comprises water and / or brine having a temperature of about 4 ° C. In some embodiments, the medicament comprises a combination of benzocaine, tetracaine, and lopivacaine. In some embodiments, the medicament comprises an anesthetic comprising about 14 weight percent benzocaine, about 2 weight percent tetracaine, and about 1 weight percent lopivacaine, based on the total weight of the anesthetic.

In some embodiments, benzocaine, tetra in order to achieve rapid onset of SPG blocks and sustain the effect of pain relief, reducing the need for repeated applications and minimizing any potential dose-related complications and / or side effects. Caine, and a mixture of lopivacaine are used. Benzocaine, which is quite effective for topical use and has a toxic dose of greater than about 200 mg, has an onset time of about 30 seconds and lasts for about 0.5 to about 1 hour. Benzocaine can provide an almost immediate onset of pain relief and increase the absorption of other local anesthetics when mixed. Ropivacaine with a toxic dose of about 175 mg typically has a slow onset but lasts for about 2 to about 6 hours. Ropivacaine provides extended neural blocks and sustained pain relief. Tetracaine is a very strong local anesthetic that has a fast onset and lasts for about 0.5 to about 1 hour. When tetracaine is used in combination with lopivacaine, the duration of pain relief exceeds 6 hours.

In some embodiments, the medicament used in accordance with the present disclosure is provided in vessel 14 (shown in FIGS. 1, 3, and 4) in a pressurized or aerosolized mixture. The medicament optionally contains preservatives, liquid carriers, and / or other inert ingredients and additives that will be readily understood by those skilled in the art.

The amount of medicament delivered in accordance with the present disclosure can be readily determined by one skilled in the art and will vary depending on factors such as the nature and / or concentration of the medicament, the age, condition, and / or sensitivity of the medicament, and the like. In some embodiments, the dosage of anesthetic is from about 0.1 cc to about 1.0 cc. In some embodiments, the dosage of anesthetic is about 0.5 cc.

The methods and devices described herein are designed for use in the treatment of all kinds of conditions where it is desirable to introduce the medicament upwards and / or laterally and / or forwards towards the patient's SPG. Representative conditions that can be treated include sphincter palatal neuralgia, central trigeminal neuralgia, e.g., pharyngeal neuralgia, migraines with or without signs, tension headaches, cluster headaches, e.g. chronic cluster headaches, paroxysmal striasis, injury Laryngeal neuralgia, atypical facial pain, herpes zoster, vasomotor rhinitis, major depression, fibromyalgia, and the like, and combinations thereof.

Topical administration of a medicament to human tissue for systemic delivery of a pharmaceutically active agent typically involves the use of pastes, creams, liquids, solids, semisolids, and the like, of transdermal and / or transmucosal membranes. However, systemic delivery of a pharmaceutically active agent by topical administration is hampered by the difficulty of diffusing the drug through the tissue to which the drug is applied to reach the blood vessel, thereby allowing the drug to be absorbed for systemic delivery. Thus, to address this difficulty, the methods and devices described herein can be applied to achieve increased permeability of the blood brain barrier in the administration of any medicament.

Conventional SPG block procedures have been used to treat a wide array of patient diseases, and the methods and apparatus described herein are designed for use in the treatment of all of them. Representative diseases include pain and / or discomfort associated with muscle spasms, vasospasm, neuralgia, reflex sympathetic dystrophy, chronic low back pain in a number of etiologies (e.g., muscular, intervertebral, arthritic, etc.), ectochondrial pain, Mandibular toothache, tongue pain, ear pain (for Eustachian tube) and middle ear lesions, secondary pain in laryngeal cancer, pain from laryngeal tuberculosis, spasms of the face and upper airways, syphilis headache, malaria headache, cluster headache, ocular migraine, dysmenorrhea, intercostal Pain (neuralgia), stomach pain, nausea and diarrhea, muscle pain in the neck muscles, rump neuralgia, maxillary neuralgia, sensory facial neuralgia, maxillary tooth pain, pain associated with extractions, sore throat, itching in the ear canal, ear herpes, taste disorders Atypical facial pain, pain teak, uterine arthritis, myofascial pain syndrome, peripheral neuropathy, post-herpes neuralgia, fractures secondary to osteoporosis, urinary hypertension, sell Including arthritis, various other arthritic conditions, and the like, and combinations thereof, but are not limited this. Additional signs in which the devices and methods described herein are intended to be used include, but are not limited to, anger control, depression relief, and the like.

As used herein, the term “kit” refers to an assembly of materials used to perform a method according to the present disclosure. Such kits include, but are not limited to, the representative devices described above, and may include one or more devices and / or elements thereof, and further include, without limitation, one or more anesthetics described above. It may include one or more medications to be used together.

In some embodiments, the kit comprises an injector and / or introducer, each shaped to engage the left nostril of the patient. In some embodiments, the kit includes an injector and / or introducer shaped to engage the right nostril of the patient. In some embodiments, the kit includes an injector and introducer shaped to engage the patient's right nostril, as well as an injector and introducer shaped to engage the patient's right nostril. If desired, exchangeable handles may also be provided for connection to the right handed or left handed introducer. In other embodiments, the handles themselves show handleability and separate handles may be provided for each of the right handed and left handed introducers.

In some embodiments, the device is provided in a fully assembled state, while in other embodiments an assembly of the device is required. In some embodiments, the device provided in the kit has a curved portion shaped for insertion into the nostril of the patient at one of the ends, such as the type described above, and is substantially cylindrical (eg, pen- or cigar). A delivery tube housed in the housing. In some embodiments, one or the plurality of elements of the device is disposable and optionally biodegradable.

The medicament provided in the kit may contain a single reagent or a plurality of reagents. Representative medications for use in accordance with the present disclosure include, but are not limited to, those described above. The medicament may be provided in combination, packaged in the same or in separate containers, and in liquid or lyophilized form, depending on its cross-reactivity and stability. The amount and ratio of any reagents provided in the kits can be selected to provide optimized results for the particular application.

The medicament included in the kit can be supplied in all kinds of containers, while the activity of the other ingredients is substantially preserved, while the ingredients themselves are not substantially altered or adsorbed by the material of the container. Suitable containers include, but are not limited to, ampoules, bottles, test tubes, vials, flasks, syringes, pouches and shells (eg, foil lined) and the like. Containers include, but are not limited to, glass, organic polymers (eg, polycarbonate, polystyrene, polyethylene, etc.), ceramics, metals (eg, aluminum), metal alloys (eg, steel), cork, and the like. It can be formed of any suitable material. The container may also include one or more sterile access ports (eg, for access through the needle), such as may be provided by the septum. Preferred materials for the bulkhead are, for example, polymers and rubbers, including but not limited to polytetrafluoroethylene of the type sold under the trade name TEFLON by DuPont (Wilmington, DE). It includes. The container may also include two or more compartments separated by partitions or membranes that can be removed to enable mixing of the components.

Kits according to the present disclosure are also known in the art and / or other items that may be desirable from a commercial and user standpoint, such as empty syringes, tubes, gauze, pads, disinfectant solutions, cleaning solutions, SPG nerve blocks Instructions for performing and / or assembling, using, and / or cleaning the apparatus, and the like, and combinations thereof.

In some embodiments, the instructions may be attached to one or more elements of the container (eg, vial) and / or device, or to a larger container in which one or more elements of the kit are packaged for transportation. Instructions may also be provided in a separate insert called a package insert. Instruction materials provided with the kit may be printed (eg on paper) and / or electronically readable media (eg, floppy disks, CD-ROMs, DVD-ROMs, straw disks, video tapes, audio tapes, etc.). Can be supplied. Apart from this, instructions may be provided by directing the user to an internet web site (eg, as specified by the manufacturer or distributor of the kit), and / or via e-mail.

The following examples illustrate the features of the apparatus and method described herein and are provided merely as an example. They are not intended to limit the scope of the appended claims or their equivalents.

Example 1-30

The devices and / or methods described above were applied to treat 30 patients suffering from chronic headaches such as migraine and tension headaches. The results of this test were surprising and unexpected. As an example, the method described above resulted in a 90% or more reduction in pain and a 100% effective SPG block in 100% of patients. The onset of pain relief was about 30 seconds to about 60 seconds and the duration of pain relief was about 4 to about 24 hours. Each SPG block was performed using only 0.5 cc or less of the anesthetic mixture containing benzocaine, tetracaine, and lopivacaine in the amounts described above. In more than 10 patients, the duration of pain relief achieved according to the present description exceeded 24 hours. Overall, very effective control of the headache was observed. The patients were able to return to work almost 100% and avoid toxic pain medications.

The devices and methods described herein are applicable to most patients over 15 years of age in a 95% population, regardless of the height, weight, gender or race of the patient. In addition, it is presently believed that the devices and methods described herein will primarily be used for the treatment of human patients, but the devices and methods may also be applied to the treatment of all kinds of non-human patients. Any non-human patient with nostrils (eg, other mammals such as primates, dogs, cats, pigs, horses, cattle, etc., and non-mammals) is likewise subject to the principles described herein. Can be treated (eg, by a veterinarian).

In summary, devices and methods have been described to provide safer and more effective relief of pain associated with headaches, facial pain, and the like. Such devices and methods can be readily used on patients by economical, trained professional practitioners, and by patients themselves without medical professional supervision, to provide reliable and repeatable delivery of medication to target locations. In some embodiments, the devices and methods described herein may be used by themselves by a patient twice per hour or as needed.

In use, any handle 20 of device 10 described herein is pushed toward the patient's face until the introducer 18 fits snugly and comfortably within the patient's nostrils, thereby pushing the patient's nose The flat tip can be raised to face up and slightly back. Thereafter, the injector 12 is pushed back toward the patient's nose so that the nozzle 28 is inward and / or back and / or bottom-in some embodiments inward and / or down, and in other embodiments. The tubular section 24 and the nozzle 28 can be slid backwards until they are inward, downward and backward. Subsequently, a medicament, such as an anesthetic, is injected and directed upwards and / or laterally and / or anteriorly—in some embodiments, laterally and / or upwardly, and in other embodiments laterally, upwardly, and anteriorly—and around it. Can be sprayed through the aperture 36 of the nozzle 28. When a suitable anesthetic is sprayed onto the SPG, fast and sustained vasoconstriction of the dorsal head or cerebrovascular can be achieved, resulting in effective pain management.

The foregoing detailed description and the accompanying drawings have been provided by way of illustration and illustration, and are not intended to limit the scope of the appended claims. Many variations in the presently preferred embodiments illustrated herein will be apparent to those skilled in the art, and remain within the scope of the appended claims and their equivalents.

Claims (20)

An injector comprising a first end shaped to enter the patient's nasal cavity and a second end shaped to enter the nasal cavity of the patient, the injector being movable between the storage position and the engaged position; And
An introducer shaped to engage the nostril of the patient, comprising a passageway shaped to slidably receive the injector and comprising a curve along their portion adjacent to the passageway
A drug delivery device to a patient in need of medicine, including. The medication delivery device of claim 1, wherein the injector comprises a flexible tube shaped to employ at least a portion of the curve of the passageway. The medication delivery device of claim 2, wherein the injector comprises one or a plurality of holes along the side of the flexible tube adjacent the second end. The medication delivery device of claim 1, further comprising a housing, wherein the first end of the housing is shaped to leave the patient's nose outside and the second end of the housing comprises an introducer. The device of claim 4, wherein the device further comprises a hub connected to the injector, wherein the hub is shaped to be connected to the syringe. 6. The medication delivery device of claim 5, wherein the hub is shaped to remain out of the housing prior to being connected to the syringe and shaped to enter the housing substantially irreversibly when pushed axially towards the introducer. The device of claim 5, wherein the hub comprises a luer lock. 6. The medication delivery device of claim 5, wherein the hub comprises a stop bar and the housing comprises a key slot shaped to receive the stop bar. The medication delivery device of claim 8, wherein the housing further comprises a lip shaped to prevent retraction of the hub from the interior of the housing. 7. The medication delivery device of claim 6, wherein the hub is shaped to rotate between a range of angles when the hub is positioned substantially within the housing, but is substantially non-rotating when positioned substantially outside the housing. The medication delivery device of claim 10 wherein the predetermined range of angles in the hub shaped to rotate are about 45 degrees clockwise and about 45 degrees counterclockwise. The medication delivery device of claim 10, wherein the hub comprises a stop bar and the housing comprises a ledge shaped opposite the stop bar on its first and second sides. Introducing an injector of the device according to claim 1 through the patient's nasal passage into a region substantially inward and / or posterior and / or downward of the patient's butterfly palate ganglion; And
Delivering medication from the injector upwards and / or laterally and / or anteriorly to the butterfly palate ganglion
Pain relief method of the patient comprising a. 14. The injector of claim 13, wherein the injector comprises a flexible tube shaped to employ at least a portion of the curve of the passageway, and the injector comprises one or a plurality of holes along the side of the flexible tube adjacent the second end. Pain Relief in Patients with Disorders. The method of claim 14, wherein the region is substantially inward and downward of the butterfly palate ganglion. The method of claim 14, wherein the region is substantially inward, downward, and posterior to the butterfly palate ganglion. The method of claim 14, wherein the medicament is delivered laterally and upwardly towards the butterfly palate ganglion. The method of claim 14, wherein the medicament is delivered laterally, up, and forward toward the butterfly palate ganglion. The method of claim 14, wherein the regions are substantially inward, downward, and posterior to the butterfly palate ganglion and the medication is delivered laterally, up, and forward toward the butterfly palate ganglion. The method of claim 14, wherein the pain comprises a headache, facial pain, or a combination thereof.

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